510(k) · Cleared
ClearedVitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002;
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · KHS Enzymatic, Carbon-Dioxide
Cleared on Apr 15, 2010 as substantially equivalent to K802376 (Eastman Kodak Company, 1980) and 2 other predicates after a 143-day review. Its family tree reaches back 6 generations to 1999.
- Decided
- Apr 15, 2010
- Review
- 143 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K984303 (1999). 18 ancestors in all, the oldest K800054 (1980). No later device cites it as a predicate yet.
- Root · 6 generations backK984303 Vitros Chemistry Products Magnetic HDL-Cholesterol ReagentOrtho-Clinical Diagnostics, Inc. · 1999
- 5 generations backK012593 Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros…Ortho-Clinical Diagnostics, Inc. · 2001 · Recalled
- 4 generations backK071801 Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S)…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- 3 generations backK073157 Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- 2 generations backK081411 Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
- 1 generation backK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
- This deviceK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K984303 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
| −5 | K012593 | Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry… | Ortho-Clinical Diagnostics, Inc. | 2001 | 1 |
| −4 | K071801 | Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| −3 | K073157 | Vitros Chemistry Products K+ Slides and Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2007 | 1 |
| −2 | K081411 | Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | 2008 | 4 |
| −1 | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2009 | — |
| 0 (this device) | K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT… | Ortho-Clinical Diagnostics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K802376 | Kodak Ekta-Chem Clinical Chem. SlidesSummary page 1…d VITROS Chemistry Products DT Calibrator Kit. The FDA cleared the VITROS Chemistry Products CO2 DT Slides on October 23, 1980 (K802376) under the product name Kodak EKTACHEM DT Clinical Chemistry Slides (C0 2 ) With the purchase of KODAK Clini… | 1980 |
| * | K091861 | Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Summary page 1…Chemistry Products CO2 DT Slides. The most recent FDA clearance for the VITROS Chemistry Products DT Calibrator Kit was September 3, 2009 (K09186 1). Additional predicate devices for the VITROS CO2 DT assay are the Corning 965 carbon dioxide… | 2009 |
| Kept off the family tree | K810257 | FDA’s K810257 is Vessel Tips, Sizes 13-18 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1981 |
| * | K001133 | Vitro Chemistry Products ECO2 Slide & Calibrator Kit 2 | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 8 of the 18 ancestors have a recall of any class.
How does its category compare?
All KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KHS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHS
143in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHS
40in 2025
MAUDE reports naming product code KHS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 14 |
| 2010 | 3 | 143 | 0 | 0 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 1 | 35 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 1 | 25 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VITROS Chemistry Products CO2 DT Slides quantitatively measure carbon dioxide (CO2) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Total carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093611 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093611: Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093611
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026